Clinical trial of a low-cost external fixator for global surgery use.

PURPOSE: A low-cost modular external fixator for the lower limb has been developed for global surgery use. The purpose of this study is to assess outcome measures in the first clinical use of the device. METHODS: A prospective cohort study was conducted with patients recruited in two trauma hospitals. Initial clinical procedure data were collected, and patients were followed up every two weeks until 12 weeks or definitive fixation. Follow-up assessed infection, stability, and radiographic outcomes. In addition, patient-reported outcomes and surgeons' feedback on device usability were collected by questionnaires. RESULTS: The external fixator was used on 17 patients. Ten were mono-lateral, five were joint spanning, and two were delta configuration. One patient had a pin site infection at 12-week follow-up. All were stable when tested mechanically and using radiographic assessment, and 53% were converted to definitive fixation. CONCLUSION: The low-cost external fixator developed is appropriate for use in global surgery trauma centres with good clinical outcomes. PROSPECTIVE TRIAL REGISTRATION NUMBER AND DATE: SLCTR/2021/025 (06 Sep 2021).

Low-cost locally manufacturable unilateral imperial external fixator for low- and middle-income countries.

Treating open fractures in long bones can be challenging and if not performed properly can lead to poor outcomes such as mal/non-union, deformity, and amputation. One of the most common methods of treating these fracture types is temporary external fixation followed by definitive fixation. The shortage of high-quality affordable external fixators is a long-recognised need, particularly in Low- and Middle-Income Countries (LMICs). This research aimed to develop a low-cost device that can be manufactured locally to international standards. This can provide surge capacity for conflict zones or in response to unpredictable incidents and situations. The fixator presented here and developed by us, the Imperial external fixator, was tested on femur and tibia specimens under 100 cycles of 100 N compression-tension and the results were compared with those of the Stryker Hoffmann 3 frame. The Imperial device was stiffer than the Stryker Hoffmann 3 with a lower median interfragmentary motion (of 0.94 vs. 1.48 mm). The low-cost, easy to use, relatively lightweight, and easy to manufacture (since minimum skillset and basic workshop equipment and materials are needed) device can address a critical shortage and need in LMICs particularly in conflict-affected regions with unpredictable demand and supply. The device is currently being piloted in three countries for road traffic accidents, gunshot wounds and other conflict trauma-including blast cohorts.

Finite element modeling of an energy storing and return prosthetic foot and implications of stiffness on rollover shape.

Energy storing and return (ESAR) prosthetic feet showed continuous improvements during the last 30 years. Despite this, standard guidelines are still missing to achieve an optimal foot design in terms of performances. One of the most important design parameters in ESAR feet is the Rollover Shape (RoS). This represents the foot Center of Pressure (CoP) path in a shank-based coordinate system during stance. RoS objectively describes the foot behavior according to its stiffness, which depends on foot geometry and material. This work presents the development of a finite element modeling methodology able to predict the stiffness characteristic of an ESAR foot and its RoS. The validation of the model is performed on a well-known commercially available prosthetic foot both in bench tests and realistic walking scenario. The obtained results confirm an error of +6.1% on stiffness estimation and +10.2% on RoS evaluation, which underlines that the proposed method is a powerful tool able to replicate the mechanical behavior of a prosthetic foot.

Survey of transfemoral amputee experience and priorities for the user-centered design of powered robotic transfemoral prostheses.

BACKGROUND: Transfemoral amputees experience a complex host of physical, psychological, and social challenges, compounded by the functional limitations of current transfemoral prostheses. However, the specific relationships between human factors and prosthesis design and performance characteristics have not yet been adequately investigated. The present study aims to address this knowledge gap. METHODS: A comprehensive single-cohort survey of 114 unilateral transfemoral amputees addressed a broad range of demographic and clinical characteristics, functional autonomy, satisfaction and attitudes towards their current prostheses, and design priorities for an ideal transfemoral prosthesis, including the possibility of active assistance from a robotic knee unit. The survey was custom-developed based on several standard questionnaires used to assess motor abilities and autonomy in activities of daily living, prosthesis satisfaction, and quality of life in lower-limb amputees. Survey data were analyzed to compare the experience (including autonomy and satisfaction) and design priorities of users of transfemoral prostheses with versus without microprocessor-controlled knee units (MPKs and NMPKs, respectively), with a subsequent analyses of cross-category correlation, principal component analysis (PCA), cost-sensitivity segmentation, and unsupervised K-means clustering applied within the most cost-sensitive participants, to identify functional groupings of users with respect to their design priorities. RESULTS: The cohort featured predominantly younger (< 50 years) traumatic male amputees with respect to the general transfemoral amputee population, with pronounced differences in age distribution and amputation etiology (traumatic vs. non-traumatic) between MPK and NMPK groups. These differences were further reflected in user experience, with MPK users reporting significantly greater overall functional autonomy, satisfaction, and sense of prosthesis ownership than those with NMPKs, in conjunction with a decreased incidence of instability and falls. Across all participants, the leading functional priorities for an ideal transfemoral prosthesis were overall stability, adaptability to variable walking velocity, and lifestyle-related functionality, while the highest-prioritized general characteristics were reliability, comfort, and weight, with highly variable prioritization of cost according to reimbursement status. PCA and user clustering analyses revealed the possibility for functionally relevant groupings of prosthesis features and users, based on their differential prioritization of these features-with implications towards prosthesis design tradeoffs. CONCLUSIONS: This study's findings support the understanding that when appropriately prescribed according to patient characteristics and needs in the context of a proactive rehabilitation program, advanced transfemoral prostheses promote patient mobility, autonomy, and overall health. Survey data indicate overall stability, modularity, and versatility as key design priorities for the continued development of transfemoral prosthesis technology. Finally, observed associations between prosthesis type, user experience, and attitudes concerning prosthesis ownership suggest both that prosthesis characteristics influence device acceptance and functional outcomes, and that psychosocial factors should be specifically and proactively addressed during the rehabilitation process.

A Randomized Controlled Trial of Eccentric Versus Concentric Cycling for Anterior Cruciate Ligament Reconstruction Rehabilitation.

BACKGROUND: Persistent strength and biomechanical deviations remain after anterior cruciate ligament reconstruction (ACLR). Eccentric training may reduce these and associated reinjury or osteoarthritis risks. HYPOTHESIS: For male patients who have undergone ACLR, eccentric training is more effective than concentric training at improving knee flexion angle and other biomechanical deviations, as well as strength and patient-reported outcomes, using a matched perceived exertion dose. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 26 men, 10-16 weeks after hamstring tendon graft ACLR, were randomized to an eccentric training group or a concentric control group. Both groups trained 3 times a week for 8 weeks using the same isokinetic cycle ergometer in a matched studio environment. Exercise dose was matched in training frequency, time, progression, and intensity using a target rating of perceived exertion. Baseline and follow-up testing included questionnaires, dynamometer strength testing, and walk/run gait analysis. RESULTS: Eccentric training increased knee (+2.1°; P = .022) and hip (+2.1°; P = .010) flexion angles more than concentric training but not more than the minimal clinically important difference of 3°. Very large asymmetries in baseline knee abduction moment (walk, -0.10 N·m/kg/m; run, -0.54 N·m/kg/m) had not changed in either group by follow-up. Knee valgus angle effects were mixed. Tibial rotation angle increased in both groups, but concentric training was more effective at promoting symmetry (P < .001). Both groups had similar increases in affected limb quadriceps strength and knee flexion moments during walk/run gait (by 20% to 33%). Hamstring strength increased in the eccentric group (+15.4%) but not the concentric group. Eccentric group limb forces were 33% to 70% higher than those of the concentric group, with a lower heart rate. Both groups had low pain scores throughout. CONCLUSION: For rehabilitation after ACLR, progressive eccentric cycle training was not more clinically effective than concentric training at a matched perceived intensity dose in male patients. This can guide exercise prescription for reducing gait and strength deviations of these patients. REGISTRATION: PACTR201602001449365 (Pan African Clinical Trials Registry), NHREC 4344 (South African).

Kinematic and kinetic gait deviations in males long after anterior cruciate ligament reconstruction.

BACKGROUND: Biomechanical deviations long (approx. 5years) after anterior cruciate ligament reconstruction have not been quantified in males, despite their distinct risk profile as compared to females. These deviations can indicate altered joint loading during chronic, repetitive motions. METHODS: Cross-sectional study, comparing kinematic and kinetic variables between 15 male anterior cruciate ligament reconstructed patients and 15 healthy controls. During walking and running gait, measurements were taken of impact dynamics, knee and hip sagittal plane angles and moments, and knee varus angles and adduction moments. FINDINGS: Comparing affected limbs to control limbs, significantly lower maximum (P=0.001) and initial (P=0.003) loading rates were found during running, but not in walking. Hip angles were lower for affected limbs of patients compared to the control group (P=0.039) in walking, but not during running. Between-limb comparisons showed important differences in symmetry of the affected patients. Maximum force during running was higher in the unaffected limb (P=0.015), which was linked with a higher loading rate (P=0.008). Knee flexion angle was reduced by 2° on average for the affected limb during running (P=0.010), and both walking and running knee and hip moments showed differences. Knee varus angle showed a 1° difference during walking (P<0.001), but not during running. Knee adduction moment was significantly lower (more valgus) during both walking and running. INTERPRETATION: Male anterior cruciate ligament reconstructed patients demonstrate persistent, clinically important gait asymmetries and differences from healthy controls long after surgery in kinematics, kinetics, and impact biomechanics.